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Prostate Cancer IRE Study (PRIS)

NCT05513443 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-01-20

No results posted yet for this study

Summary

The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.

Conditions

Interventions

PROCEDURE

Irreversible electroporation, IRE

IRE involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death. The technique is used in Sweden today in radical ablative therapies in the treatment of tumors in the liver, kidney and pancreas. Prior to treatment a Foley catheter is placed. During the treatment, which takes place under anesthesia, the patient is placed in gynecological position and the tumour lesion is located with BK transrectal fusion ultrasound. Thereafter the needles are placed transperineal around the tumor in the prostate using a brachytherapy grid (17Ga Civco brachytherapy grid), guided by the ultrasound/MRI fusion images. Through the needles electrical pulses are then sent to treat the tumor in the center using the Nanoknife technique. After treatment patients are treated with diuretics to flush the kidneys post treatment.

PROCEDURE

Radical prostatectomy

Radical prostatectomy

RADIATION

Radiation therapy

Radiation therapy for prostate cancer

Sponsors & Collaborators

Principal Investigators

  • Anna Lantz, Ass Prof · Karolinska University Hospital and Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-02-01
Completion
2026-09-01

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513443 on ClinicalTrials.gov